The Prone to Supine Breast MRI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of Successful Segmentation of Supine MRI Images
研究概览
简要总结
The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.
详细描述
The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.
These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Female gender.
- •Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- •Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- •A diagnostic breast MRI is considered to be clinically indicated.
- •Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
排除标准
- •Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- •Severe claustrophobia.
- •Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
- •History of median sternotomy.
- •Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- •Patients who have received neoadjuvant chemotherapy.
结局指标
主要结局
Number of Successful Segmentation of Supine MRI Images
时间窗: 30 minutes
Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.
次要结局
- Time to Position and Obtain Supine Images(30 Minutes)
- Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor(30 minutes)
- Enhancement Quantification- Tumor-to-Background Ratio(30 minutes)
- Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary(30 minutes)
- Overall Comfort for Prone and Supine Positions(Within 15 minutes of the scan)
研究者
Timothy B. Rooney
MD
Dartmouth-Hitchcock Medical Center